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FDA 510(k)

NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER

K-Number: K110627 · 2011-08-12

ApplicantMarvao Medical Devices, Ltd.
Decision Date2011-08-12
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Marvao Medical Devices, Ltd.. It received FDA 510(k) clearance on 2011-08-12 under 510(k) number K110627. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER?

NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER is a medical device that received FDA 510(k) clearance on 2011-08-12. The listed applicant is Marvao Medical Devices, Ltd.. The 510(k) number is K110627.

When did NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER receive FDA 510(k) clearance?

NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER received FDA 510(k) clearance on 2011-08-12, under 510(k) number K110627.

Who is the listed applicant for NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER?

The FDA 510(k) record lists Marvao Medical Devices, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER?

The FDA product code for NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER is LJS.

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Other records listing Marvao Medical Devices, Ltd. as applicant

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Related Devices (Code: LJS)

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K260929Neonav ECG Tip Location SystemNavi Medical TechnologiesK252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve TechnologySpectrum VascularK252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); HydrAccess Vascular, Inc.K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)Access Vascular, Inc.K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc.

Official Source

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